Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02812316
Other study ID # 201210038
Secondary ID
Status Active, not recruiting
Phase N/A
First received February 26, 2016
Last updated April 25, 2017
Start date August 2014
Est. completion date October 2017

Study information

Verified date November 2016
Source Taipei Medical University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Study to evaluate the safety and efficacy of HI-BRITE large diameter rigid gas permeable contact lens (hexafocon b) test when worn on a daily wear basis in the correction of myopia/hyperopia/astigmatism/presbyopia/ and irregular cornea.


Description:

Subjects who meet all eligible requirements for entry into the study will be instructed to insert the Hi-Brite Large Diameter Rigid Gas Permeable contact lens in daily wear basis for clinical evaluation purposes.

Treatment period: 6 months


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 136
Est. completion date October 2017
Est. primary completion date February 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 65 Years
Eligibility Inclusion criteria:

- Ametropic or irregular cornea subjects who need to wear spectacle lens or contact lens in their daily life.

- Is of age at least 20 years old and no older than 65 years old capacity to volunteer.

- Has read and signed the Informed Consent Form or waiver. (4) Has myopia or hyperopia -20.00D~+20.00D, astigmatism -0.25~-4.00D, or presbyopia +1.00D~+3.50D.

- Irregular cornea subjects include keratoconus, high astigmatism (>-4.00D) or post-refractive surgery patients.

- No active ocular disease, infection or any disorder of eyelids and conjunctiva.

- Has reasonable expectation of improvement in visual acuity with the test lenses.

- Is willing and able to follow subject instructions and meet the protocol -specified visit schedule. (If subjects missed any visit, they must be discontinued from the study.) (9) Agrees to wear the test lenses at a daily wear basis. (10) Willing to adapt wearing GP contact lens.

Exclusion criteria:

The subject is ineligible for entry into the study if the subject

- Has any systemic disease affecting ocular health.

- Is using any systemic or topical medications that will, in the Investigator's opinion. Affect ocular physiology or lens performance within one (1) week before entering this study.

- Has an active ocular disease or has ever used systemic steroid or any other medicine that may affect significant on vision or healing.

- Has any Grade 2 or greater finding listed in the Quantification of Slit Lamp Observations Form. Subjects with corneal infiltrates, however, of ANY GRADE, are not eligible.

- Has any "Present" finding listed in the Quantification of Slit Lamp Observations that, in the Investigators' judgment, interferes with contact lens wear.

- Has any scar or neovascularization within the central 4mm of the cornea. Subjects with minor peripheral corneal scarring that, in the Investigator's judgment, does not interfere with contact lens wear are eligible for this study.

- Severe dry eye (Schirmer Test<5mm/5min)

- Corneal keratitis

- Is aphakic

- Had undertaken the following surgery: Retina, Glaucoma, Cataract surgery.

- Is amblyopic, BSCVA can't achieve (include) 20/40(0.5) when wear trial lenses.

- Allergy to contact lens solution.

- ls participating in any other clinical research study.

- Pregnancy or Breast-feeding.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
HI-BRITE Large Diameter Rigid Gas Permeable Contact Lens
Approximately At least one hundred and forty (140) subjects (280 eyes) will be enrolled in this study at approximately two (2) clinical sites in Taiwan. All subjects will be fitted for and dispensed study lenses by each Investigator.

Locations

Country Name City State
Taiwan Taipei Medical University Hospital Taipei

Sponsors (1)

Lead Sponsor Collaborator
Taipei Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary The success rate of the vision with correction Ametropic group: Subjects wear their lens for at least 6 hours/day and 5 days/ week after visit 9, Distance Lens VA is not less than 20/25 and 90% subjects' VA decreased less than 2 lines with Snellen's chart at the last visit.
Irregular Cornea Group: Subjects wear their lens for at least 6 hours/day and 5 days/ week after visit 9, Distance Lens VA is not less than 20/40 and 80% subjects' VA decreased less than 2 lines with Snellen's chart at the last visit.
Wearing the contact lens for 6 months
Secondary The effectiveness of each visit Ametropic group: To assess each subject for the lens satisfied / problem and assess each time of the vision with correction; the ratio of ametropic correcting vision of 20/25 subjects.
Irregular Cornea Group: To assess each subject for the lens satisfied / problem and assess each time of the vision with correction; the ratio of the irregular cornea corrected visual acuity of 20/40 subjects.
wearing the contact lens for 6 months
Secondary The rate of Treatment-Emergent Adverse Events to assess the safety of each visit To assess the rate of adverse reactions, the proportion of corneal ulcers, the proportion of continuous stroma edema, significant proportion of corneal staining of luciferase, the proportion of corneal infections, the proportion of persistent inflammation of the eyelids, and the proportion of other eye discomfort. wearing the contact lens for 6 months
See also
  Status Clinical Trial Phase
Completed NCT04532099 - Clinical Comparison of Two Daily Wear Frequent Replacement Silicone Hydrogel Soft Contact Lenses N/A
Completed NCT05039112 - Clinical Comparison of 2 Daily Disposable Toric Soft Contact Lenses N/A
Completed NCT03670303 - Trial of an Educational Intervention to Promote Spectacle Use Among Secondary School Children in Islamabad, Pakistan N/A
Completed NCT02255474 - Bifocal Lenses In Nearsighted Kids N/A
Not yet recruiting NCT03222661 - Direct Comparison of SVOne Obtained Refraction to Subjective Manifest Refraction N/A
Completed NCT04055519 - Clinical Performance Assessment of a Daily Wear Monthly Replacement Soft Silicone Hydrogel Contact Lens N/A
Recruiting NCT05049070 - Study to Evaluate the Reliability, Validity and Safety of Subjective Mobile Refraction N/A
Completed NCT04527978 - Clinical Comparison of 2 Daily Disposable Contact Lenses - Pilot Study 1 N/A
Completed NCT01430247 - Vision Screening for the Detection of Amblyopia N/A
Recruiting NCT06077682 - Cycloplegic Refraction in Pediatric Patients With Esotropia Phase 4
Not yet recruiting NCT04077086 - Correcting Myopia Among Secondary School Children to Increase Academic High School Attendance Rates in Rural Communities N/A
Withdrawn NCT04352868 - Customizing Myopia Control With Multifocal Toric Contact Lens N/A
Completed NCT04528017 - Clinical Comparison of 2 Daily Disposable Contact Lenses - Pilot Study 2 N/A
Recruiting NCT04338880 - Academic Performance and Refractive Error
Recruiting NCT04545073 - Outcomes of a Trifocal IOL in Post-refractive Patients
Enrolling by invitation NCT05992675 - Air Optix® Night and Day® Aqua Continuous Wear
Enrolling by invitation NCT05976750 - Air Optix® Night and Day® Aqua Daily Wear
Recruiting NCT04693247 - Handheld Device Compared With a Standard Eye Care Diagnostic Device in Measuring Ophthalmic Refraction N/A
Recruiting NCT06065631 - Seeing to Learn in Sierra Leone N/A
Not yet recruiting NCT05550740 - Repeated Low-Level Red-Light Therapy for Shortening Axial Length N/A